Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, vildagliptin, metformin combination
Eligibility Criteria
Inclusion Criteria:
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method
- Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
- Agreement to maintain the same dose of metformin throughout the study
- Age in the range of 18-85 years inclusive.
- HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
- Agreement to maintain prior diet and exercise habits during the full course of the study
- Ability to comply with all study requirements and signed informed consent to participate in the study.
Exclusion Criteria:
- Pregnant or lactating female
A history of:
- type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
- acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
Any of the following significant laboratory abnormalities:
- ALT, AST greater than 2 times the upper limit of the normal range at visit 1.
- Direct bilirubin greater than the upper limit of the normal range at visit 1.
- Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit 1.
- Clinically significant TSH values outside of normal range at visit 1.
- Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c
Secondary Outcome Measures
Change from baseline in fasting plasma glucose
Adverse event profiles including gastrointestinal tolerability and hypoglycemia
Responder rates
Change from baseline in insulin and proinsulin in a subgroup of patients
Change in systolic and diastolic blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00494884
Brief Title
Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
Official Title
A Multicenter, Randomized, Double-blind, Parallel-group Study to Investigate the Glucose Lowering Effect, Safety and Tolerability of 24 Weeks Treatment With Vildagliptin 100 mg o.d. Versus Placebo Followed by a 12 Weeks Treatment Period With Open-label Vildagliptin 100 mg o.d. as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes, vildagliptin, metformin combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in fasting plasma glucose
Time Frame
24 weeks
Title
Adverse event profiles including gastrointestinal tolerability and hypoglycemia
Time Frame
24 weeks
Title
Responder rates
Time Frame
24 weeks
Title
Change from baseline in insulin and proinsulin in a subgroup of patients
Time Frame
24 weeks
Title
Change in systolic and diastolic blood pressure
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Eligibility Criteria
Inclusion Criteria:
Male, non-fertile female or female of childbearing potential using a medically approved birth control method
Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
Agreement to maintain the same dose of metformin throughout the study
Age in the range of 18-85 years inclusive.
HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
Agreement to maintain prior diet and exercise habits during the full course of the study
Ability to comply with all study requirements and signed informed consent to participate in the study.
Exclusion Criteria:
Pregnant or lactating female
A history of:
type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
Any of the following significant laboratory abnormalities:
ALT, AST greater than 2 times the upper limit of the normal range at visit 1.
Direct bilirubin greater than the upper limit of the normal range at visit 1.
Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit 1.
Clinically significant TSH values outside of normal range at visit 1.
Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. W. E. Schmidt
Organizational Affiliation
Ruhr-Universitat Bochum, Medizinische Klinik, St. Josef Hospital, Gudrunstr. 56, D-44791 Bochum, Telefon: 0234-509-2311, Telefax: 0234-509-2309
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bochum
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
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